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CKD-330 Drug-Drug Interaction Study (Amlodipine) (CKD-330(A))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02064556
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine monotherapy.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine 10mg Drug: Amlodipine 10mg/Candesartan 32mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Amlodipine Between Free Combination of Amlodipine and Candesartan and Amlodipine Monotherapy in Healthy Male Volunteers
Study Start Date : May 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: A(Amlodipine 10mg)
Amlodipine 10mg 1T, PO, QD for 9days
Drug: Amlodipine 10mg/Candesartan 32mg
Amlodipine 10mg 1T, PO, QD for 9days/Candesartan 32mg 1T, PO, QD for 9days
Other Name: Norvasc Tab. 10mg/Atacand Tab. 32mg

Experimental: B(Amlodipine 10mg/Candesartan 32mg)
Amlodipine 10mg 1T, PO, QD for 9days/Candesartan 32mg 1T, PO, QD for 9days
Drug: Amlodipine 10mg
Amlodipine 10mg 1T, PO, QD for 9days
Other Name: Norvasc Tab. 10mg




Primary Outcome Measures :
  1. AUCτ,ss of Amlodipine [ Time Frame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h ]
  2. Cmax,ss of Amlodipine [ Time Frame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h ]

Secondary Outcome Measures :
  1. Tmax,ss of Amlodipine [ Time Frame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male volunteer is between 20 and 45 years of age(inclusive) at the pre-study(screening).
  2. Volunteer who has 19kg/m² ≤ BMI(Body Mass Index) ≤ 26kg/m²
  3. When volunteer in screening, Must include under the items.

    1. 100 mmHg ≤ sitting SBP <140 mmHg
    2. 60 mmHg ≤ sitting DBP < 90 mmHg
    3. 45 bpm ≤ Pulse < 95 bpm
  4. Those who decided to join the clinical trials by themselves and to comply with the precautions written consent.

Exclusion Criteria:

  1. A previous history or present of clinically significant liver, renal, gastro-intestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, cardiovascular disease.
  2. Have a gastrointestinal disease history that can affect drug absorption(Crohn's disease, Ulcers, GERD, Gastritis, etc.) or surgery (except simple appendectomy or hernia surgery).
  3. The history of clinically significant hypersensitivity reaction about Investigational drugs and foods.
  4. The history of drug abuse or drug abuse showed a positive for urine drug test.
  5. Taking drugs have received any other investigational drug within 90 days prior to the first dosing and metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing.
  6. Whole blood donation within 60 days prior to the first dosing or plasma donation within 30 days prior to the first dosing.
  7. Taking drugs that clinical trials expected to affect within 14days or taking food containing caffeine, grapefruit within 7days before the first dosing.
  8. A heavy alcohol consumer(alcohol>3cup/day or 3times/week within last 1month)
  9. A heavy smoker(cigarette>10cigarettes/day)
  10. The subject has positive results of serum tests(Hepatitis B, C, HIV Test, Syphilis).
  11. Have the Liver enzyme levels(AST, ALT) or Bilirubin, total results greater than 1.5 times the UNL.
  12. Have the result of Creatinine clearance is less than 80mL/min(Cockcroft-Gault equation applicable).
  13. The result of 12-lead ECG in screening test is QTc>450msec.
  14. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064556


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Kyun-Seop Bae, Professor Asan Medical Center
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02064556    
Other Study ID Numbers: 144HPS13012
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Candesartan
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists